Efficacy of intralesional recombinant human epidermal growth factor in diabetic foot ulcers in <scp>M</scp>exican patients: A randomized double‐blinded controlled trial

Gomez-Villa, Ramiro; Aguilar-Rebolledo, Francisco; Lozano-Platonoff, Adriana; Teran-Soto, Juan Miguel; Fabian-Victoriano, Maria Rosy; Kresch-Tronik, Nicole S.; Garrido-Espíndola, Ximena; Garcia-Solis, Adriana; Bondani-Guasti, Augusto; Bierzwinsky-Sneider, Guillermo; Contreras‐Ruiz, José

doi:10.1111/wrr.12187

Cited by 63 publications

(82 citation statements)

References 36 publications

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“…A total of 837 articles were obtained of which 26 were found to be eligible to be included for final analysis (Figure ). There were a total of 2088 participants with 1018 events from all these eligible studies.…”

Section: Resultsmentioning

confidence: 99%

Growth factors for diabetic foot ulcers: mixed treatment comparison analysis of randomized clinical trials

Sridharan

Sivaramakrishnan

2018

Brit J Clinical Pharma

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Keywords autologous platelet transfusion, epidermal growth factor, platelet derived growth factor AIMS Topical growth factors accelerate wound healing in patients with diabetic foot ulcers (DFU). Due to the absence of head-to-head comparisons, we carried out Bayesian network meta-analysis to compare the efficacy and safety of growth factors. METHODSUsing an appropriate search strategy, randomized controlled trials on topical growth factors compared with standard of care in patients with DFU, were included. Proportion of patients with complete healing was the primary outcome. Odds ratio (95% confidence interval) was used as the effect estimate and random effects model was used for both direct and indirect comparisons. Markov Chain Monte Carlo simulation was used to obtain pooled estimates. Rankogram was generated based on surface under the cumulative ranking curve (SUCRA). RESULTSA total of 26 studies with 2088 participants and 1018 events were included. The pooled estimates for recombinant epidermal growth factor (rhEGF), autologous platelet rich plasma (PRP), recombinant human platelet-derived growth factor (rhPDGF) were 5.72 [3.34, 10.37], 2.65 [1.60, 4.54] and 1.97 [1.54, 2.55] respectively. SUCRA for rhEGF was 0.95. Sensitivity analyses did not reveal significant changes from the pooled estimates and rankogram. No differences were observed in the overall risk of adverse events between the growth factors. However, the growth factors were observed to lower the risk of lower limb amputation compared to standard of care. CONCLUSIONTo conclude, rhEGF, rhPDGF and autologous PRP significantly improved the healing rate when used as adjuvants to standard of care, of which rhEGF may perform better than other growth factors. The strength of most of the outcomes assessed was low and the findings may not be applicable for DFU with infection or osteomyelitis. The findings of this study needs to be considered with caution as the results might change with findings from head-to-head studies.British Journal of Clinical Pharmacology Br J Clin Pharmacol (2018) 84 434-444 434

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Section: Resultsmentioning

confidence: 99%

Growth factors for diabetic foot ulcers: mixed treatment comparison analysis of randomized clinical trials

Sridharan

Sivaramakrishnan

2018

Brit J Clinical Pharma

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“…Several small trials have been published from Asia and Cuba attesting to the healing benefits of EGF compared with controls. [207][208][209]213 However, the heterogeneity of wounds, applications, patient management protocols, and outcomes has not lead to clinical trials in the United States nor to widespread global adoption of this therapy.…”

Section: Biological and Bioengineered Therapiesmentioning

confidence: 98%

“…200,202,204 rhEGF is perhaps the best studied growth factor for cutaneous ulcers and wounds, but is not available in the United States. [205][206][207][208][209][210][211][212] Applied as a topical cream, or more commonly, by intralesional injections, EGF has been found also to expedite the healing of a variety of types of cutaneous wounds. Several small trials have been published from Asia and Cuba attesting to the healing benefits of EGF compared with controls.…”

Section: Biological and Bioengineered Therapiesmentioning

confidence: 99%

Challenges in the Treatment of Chronic Wounds

Frykberg

Banks

2015

Advances in Wound Care

1,816

1,429

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Significance: Chronic wounds include, but are not limited, to diabetic foot ulcers, venous leg ulcers, and pressure ulcers. They are a challenge to wound care professionals and consume a great deal of healthcare resources around the globe. This review discusses the pathophysiology of complex chronic wounds and the means and modalities currently available to achieve healing in such patients.Recent Advances: Although often difficult to treat, an understanding of the underlying pathophysiology and specific attention toward managing these perturbations can often lead to successful healing.Critical Issues: Overcoming the factors that contribute to delayed healing are key components of a comprehensive approach to wound care and present the primary challenges to the treatment of chronic wounds. When wounds fail to achieve sufficient healing after 4 weeks of standard care, reassessment of underlying pathology and consideration of the need for advanced therapeutic agents should be undertaken. However, selection of an appropriate therapy is often not evidence based.Future Directions: Basic tenets of care need to be routinely followed, and a systematic evaluation of patients and their wounds will also facilitate appropriate care. Underlying pathologies, which result in the failure of these wounds to heal, differ among various types of chronic wounds. A better understanding of the differences between various types of chronic wounds at the molecular and cellular levels should improve our treatment approaches, leading to better healing rates, and facilitate the development of new more effective therapies. More evidence for the efficacy of current and future advanced wound therapies is required for their appropriate use.

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“…More recent studies have found some benefit in healing, although they are very small studies with high risk of bias. [68][69][70] Vascular endothelial growth factor. There has only been one RCT evaluating the efficacy of VEGF in DFUs.…”

Section: Human Growth Factorsmentioning

confidence: 99%

Update on management of diabetic foot ulcers

Everett

Mathioudakis

2018

Annals of the New York Academy of Sciences

616

403

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Diabetic foot ulcers (DFUs) are a serious complication of diabetes that results in significant morbidity and mortality. Mortality rates associated with the development of a DFU are estimated to be 5% in the first 12 months, and 5-year morality rates have been estimated at 42%. The standard practices in DFU management include surgical debridement, dressings to facilitate a moist wound environment and exudate control, wound off-loading, vascular assessment, and infection and glycemic control. These practices are best coordinated by a multidisciplinary diabetic foot wound clinic. Even with this comprehensive approach, there is still room for improvement in DFU outcomes. Several adjuvant therapies have been studied to reduce DFU healing times and amputation rates. We reviewed the rationale and guidelines for current standard of care practices and reviewed the evidence for the efficacy of adjuvant agents. The adjuvant therapies reviewed include the following categories: nonsurgical debridement agents, dressings and topical agents, oxygen therapies, negative pressure wound therapy, acellular bioproducts, human growth factors, energy-based therapies, and systemic therapies. Many of these agents have been found to be beneficial in improving wound healing rates, although a large proportion of the data are small, randomized controlled trials with high risks of bias.

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Efficacy of intralesional recombinant human epidermal growth factor in diabetic foot ulcers in Mexican patients: A randomized double‐blinded controlled trial

Cited by 63 publications

References 36 publications

Growth factors for diabetic foot ulcers: mixed treatment comparison analysis of randomized clinical trials

Growth factors for diabetic foot ulcers: mixed treatment comparison analysis of randomized clinical trials

Challenges in the Treatment of Chronic Wounds

Update on management of diabetic foot ulcers

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